11 results
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23ms
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Sources: EU EUDAMED, US FDA
Abiomed 14Fr Low Profile Introducer Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
TRIAL RING D.50
FDA UDI
FOURNITURES HOSPITALIERES INDUSTRIE·03661489417085·
Tyber Medical
FDA UDI
Tyber Medical, LLC·M695502P241708S1·PLIF 24mm x 8mm x 17mm x 0 °, TyPEEK, Sterile
Tyber Medical
FDA UDI
Tyber Medical, LLC·M695302P241708S1·PLIF 24mm x 8mm x 17mm x 0 °, PEEK, Sterile
ENPATH SAFETY INTRODUCER
FDA 510(k)
FDA Class 2
·Cardiovascular
ULTRASHAPE SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BD ANGIOCATH¿ IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.·Product code FOZ·December 10, 2018
GIA 80-3.8 SINGLE USE RELOADABLE STAPLER
FDA Adverse Event
Injury
·PONCE - USS·Product code GDW·November 19, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 9, 2011
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 22, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillators (ICDs) provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy. Boston Scientific implantable cardioverter defibrillators (ICDs) are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 29, 2014